Actively Recruiting
A Randomized Phase 2 Study Assessing the Efficacy and Safety of Olvimulogene Nanivacirepvec Followed by Platinum-doublet Chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor Compared With Docetaxel in Patients With NSCL Cancer After First Progression While on Front-line Immune Checkpoint Inhibitor-based Maintenance
Led by Genelux Corporation · Updated on 2026-06-04
142
Participants Needed
15
Research Sites
125 weeks
Total Duration
On this page
Sponsors
G
Genelux Corporation
Lead Sponsor
N
Newsoara Biopharma Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Olvimulogene nanivacirepvec (Olvi-Vec), an intravenously delivered oncolytic vaccinia virus, in combination with platinum-based chemotherapy and a physician's choice of immune checkpoint inhibitor (ICI) compared to docetaxel in patients with advanced or metastatic non-small-cell lung cancer (NSCLC). This Phase 2, open-label, randomized study focuses on patients who have shown first disease progression while on front-line or maintenance ICI therapy following platinum-doublet chemotherapy. The study aims to test if Olvi-Vec can activate the immune system and make tumors more responsive to chemotherapy in NSCLC patients without certain targetable genetic alterations. Participants will be assigned to one of several groups. Initial cohorts receive varying doses of Olvi-Vec over 3 or 4 consecutive days, followed 2 to 3 weeks later by platinum-doublet chemotherapy combined with a physician-chosen ICI. The experimental arm will use the Olvi-Vec dose and schedule selected from these cohorts, followed by platinum-based chemotherapy plus ICI. The comparator arm receives docetaxel starting in week 0 and continuing until disease progression is confirmed. Patients in the comparator arm with disease progression may cross over to receive the experimental treatment if eligible. During the study, participants will undergo regular assessments including imaging scans to measure tumor response and progression-free survival up to 12 months after randomization. Researchers will monitor treatment safety and side effects for up to 36 months. Additional measures include overall survival, disease control rate, and treatment response duration. Scheduled visits will involve laboratory tests, imaging, and clinical evaluations to track health and disease status throughout the trial.
CONDITIONS
Brief Title
Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed advanced or metastatic non-small-cell lung cancer
- Stage III or IV squamous or nonsquamous NSCLC as per AJCC 8th edition
- Received at least 2 and up to 6 cycles of front-line platinum-based chemotherapy with immune checkpoint inhibitor therapy
- Experienced first disease progression by radiological assessment while on front-line or maintenance immune checkpoint inhibitor therapy
- At least one measurable target tumor lesion outside the brain per RECIST 1.1 by CT or MRI scan
- Adequate kidney, liver, bone marrow, and immune function as per lab tests
- Negative pregnancy test for women of child-bearing potential before starting treatment
- Willing and able to comply with scheduled visits, treatment plan, imaging, and lab tests
You will not qualify if you...
- Active and untreated urinary tract infection, pneumonia, or other systemic infections
- Current symptomatic central nervous system metastasis
- Any uncontrolled systemic disease or condition interfering with treatment evaluation or safety
- Persistent severe toxicities (Grade 3 or higher) from prior anticancer therapy, excluding alopecia and vitiligo
- Use of additional immunosuppressive drugs beyond corticosteroids or high maintenance doses of prednisone (>10 mg daily)
- Concurrent antiviral treatment active against vaccinia virus
- Major surgery within 4 weeks before planned first dose or insufficient recovery from surgery
- Prior virus-based gene or cytolytic virus therapy
- Vaccination against smallpox or monkeypox within 1 year before study therapy
- Non-oncology vaccinations, including influenza or COVID-19 vaccines, within 2 weeks before first dose
- Significant skin diseases such as severe eczema or psoriasis
- Known allergy to carboplatin, cisplatin, paclitaxel, nab-paclitaxel, docetaxel, or Olvi-Vec components
- Severe hypersensitivity to immune checkpoint inhibitors or their excipients
- Dementia, altered mental status, or psychiatric/social conditions limiting consent or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 to 5 weeks
Participants in initial cohorts receive Olvimulogene nanivacirepvec over 3 to 4 consecutive days followed 2 to 3 weeks later by platinum-doublet chemotherapy plus Physician's Choice of Immune Checkpoint Inhibitor.
1 to 2 visits depending on cohort schedule
Duration - Until disease progression
Participants receive either (1) Olvimulogene nanivacirepvec at the dose and schedule selected from run-in cohorts followed 2 to 3 weeks later by platinum-doublet chemotherapy plus Physician's Choice of Immune Checkpoint Inhibitor, or (2) docetaxel chemotherapy until disease progression. Participants in the docetaxel arm who experience disease progression may cross over to the experimental treatment.
Regular visits for treatment administration and monitoring as per local practice
Trial Site Locations
Total: 15 locations
1
Pioneer Research Center, LLC
Bullhead City, Arizona, United States, 86442
Actively Recruiting
2
Clermont Oncology Center
Clermont, Florida, United States, 34711
Actively Recruiting
3
Oncology & Hematology Associates of West Broward
Coral Springs, Florida, United States, 33065
Actively Recruiting
4
Helios Clinical Research
Fort Lauderdale, Florida, United States, 33316
Actively Recruiting
5
Bioresearch Partner
Hialeah, Florida, United States, 33013
Actively Recruiting
6
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
7
Bioresearch Partner
Miami, Florida, United States, 33155
Actively Recruiting
8
Mid Florida Hematology and Oncology Center
Orange City, Florida, United States, 32763
Actively Recruiting
9
BRCR Medical Center, Inc.
Plantation, Florida, United States, 33322
Actively Recruiting
10
Michigan Hematology and Oncology Consultants
Dearborn, Michigan, United States, 48126
Actively Recruiting
11
Oakland Medical Group
Farmington Hills, Michigan, United States, 48336
Actively Recruiting
12
Inspira Medical Center Mullica Hill
Mullica Hill, New Jersey, United States, 08062
Actively Recruiting
13
Gabrail Cancer and Research Center
Canton, Ohio, United States, 44718
Actively Recruiting
14
Texas Oncology - Austin Central
Austin, Texas, United States, 78745
Actively Recruiting
15
World Research Link
Baytown, Texas, United States, 77521
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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